Abstract
Ethical dilemmas
I have had to consider the ethical dilemmas of ‘What is research?’ and ‘What needs ethical approval?’ over recent months when making a final decision on papers submitted for publication in the Journal. They were decisions that were not made lightly or easily or alone. I shared anonymous details and consulted other members of the Editorial team, members of the British Orthodontic Society Governance Directorate and Ethics and Standards committee, the Health Research Authority (HRA) and sort guidance from the Committee on Publication Ethics (COPE) website.
From the HRA the feedback was that “We agree with your view in your email below that an ethical opinion should have been sought for this project as it involves ionising radiation, or the researchers should have contacted us for advice if they were unsure. It is also not clear below if the patients are NHS or non-NHS patients or if the clinical data used is identifiable or not. If the study does involve identifiable data used without seeking participant consent, then an application to CAG* would have also been required. This applies to both research, and non-research projects.”
Advice from the COPE council about a similar case was that “Accessing patients’ medical records in most countries requires prior approval to make sure that privacy is preserved, that only the necessary records are used, that the data are appropriately de-identified, and to allow for reasonable oversight to verify that those standards are maintained. It is important to verify that this is the case.”
What is research?
I think we all recognise that a randomised controlled trial of competing interventions or a qualitative study involving interviews with participants are research studies and know that ethical approval is required prior to commencement of any such study. However, when it comes to retrospective research, the position is less clear. For example, what if we want to assess the outcome of the treatment we have provided? As orthodontists we are good at keeping records. Nowadays, everything can be stored digitally so, the physical act of gathering data from these records becomes easier. We can sit at the computer and compile vast Excel spreadsheets of data without leaving our desks to enter the dusty world of the model box or long-term storage room.
Audit, service evaluation or research?
There are three broad types of investigation that we could use to answer our question – audit, service evaluation and research. All these methods of investigation can give us results that may instigate changes in the provision of care for patients that lead to quality improvement.
Audit projects are designed to find out whether treatment or a service meets a defined standard whereas service evaluations are designed to answer the question ‘What standard does this service achieve?’ and research studies are designed and conducted to generate new knowledge (Health Research Authority 2022). Audit projects and service evaluations are generally designed to assess a local service and their results can be used to improve that service however, the design and conduct of research studies means that the results may be generalisable to other populations with the same condition and/or receiving the same intervention.
Whilst policies vary for each of these methods of investigation according to the regulations the country in which they are carried out, the broad principles appear to be similar (Jamtvedt et al., 2019). Audits and service evaluations are usually registered with and overseen by an institutional body for example local audit, governance or quality improvement department and they do not require ethical approval. However, research involving direct interaction with human participants or access to their clinical records to collect data, does require prior ethical approval.
So, how do we decide what is audit, service evaluation or research? Fortunately, in the UK, the HRA has compiled a useful table (HRA, 2022) and there is a helpful decision tool website (www.hra-decisiontools.org.uk/research/index.html). Figure 1. When working through this for the submissions in question, there were two defining criteria. The first was that statistical methods had been used to obtain results that may then be considered as generalisable from the sample to other populations. This was defined as a key feature of research.
HRA Decision tool - Research.
What needs ethical approval?
A summary would suggest ethical approval is needed when there is involvement of:
Human Participation.
Human Data.
Human Tissue or Biological Samples.
Vulnerable Population.
Deception or Risk.
The decision tool website assists further.
Having decided that the submissions in question were research, the decision tool then lead me to ask, “Do I need NHS REC review?’. Figure 2. One of the key questions within the decision tool at this stage is “Does your study involve ionising radiation?” This was the second defining feature of the papers under consideration because a caveat for this question is “This includes any ionising radiation research exposures, including those that are standard care”. This applied to both submissions and probably applies to many orthodontic studies whether prospective or retrospective.
HRA Decision tool – Ethical approval.
Outcome
For the submissions that caused these dilemmas, there was agreement that they were research and ethical approval should have been sort before they were undertaken so the difficult decision was made to reject them.
*Confidentiality Advisory Group https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/
